SOLIAN

What it is

Solian contains amisulpride and is available in tablets of 50 mg, 100 mg, 200 mg or 400 mg. The tablets contain lactose as an excipient and are gluten free.

Approved indications

Solian is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

Dosing overview

For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended, and in individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 800 mg/d have not been shown to be superior to lower doses and may increase the incidence of adverse events. For patients characterised by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Maintenance treatment should be established individually with the minimally effective dose. Doses should preferably be administered before meals, and Solian should be administered twice daily for doses above 400 mg.

Key safety warnings

Neuroleptic malignant syndrome is a potentially fatal syndrome that may occur with Solian, characterised by hyperthermia, muscle rigidity, rhabdomyolysis, autonomic instability, and elevated CPK, and all antipsychotic medicines including Solian should be discontinued if any symptoms suggesting NMS occur. Solian produces a dose-dependent prolongation of the QT interval, which is known to potentiate the risk of occurrence of serious ventricular arrhythmias such as torsades de pointes. Before administration, it is recommended to monitor factors which could favour the onset of this rhythm disorder, for example bradycardia less than 55 bpm, electrolyte imbalance particularly hypokalaemia, congenital prolongation of the QT interval, and on-going treatment with medications likely to produce pronounced bradycardia or prolongation of the QT interval. Leucopenia, neutropenia and agranulocytosis have been reported with Solian, and unexplained infections or fever may be evidence of blood dyscrasia and requires immediate haematological investigation. Solian causes an increase in plasma prolactin levels which is reversible after discontinuation, and this may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, orgasmic dysfunction and impotence. Solian can lower the seizure threshold, and therefore patients with a history of seizures should be closely monitored during Solian therapy.

Contraindications

Solian is contraindicated in patients with hypersensitivity to the active ingredient or other ingredients, concomitant prolactin-dependent tumours such as pituitary gland prolactinomas and breast cancer, phaeochromocytoma, children up to puberty, and during lactation. Solian is also contraindicated in combination with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine and disopyramide, Class III antiarrhythmic agents such as amiodarone and sotalol, and other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine, and sparfloxacin. Solian is contraindicated with levodopa due to reciprocal antagonism between levodopa and neuroleptics.

PBS listing

Solian oral solution 100 mg per mL, 60 mL is listed on the PBS as 1 item with streamlined restriction, with an ex-manufacturer price of A$60.17.

Regulatory history

Solian 400 mg tablets were first listed on the ARTG on 2002-02-01, followed by the oral solution 100 mg/mL on 2004-02-12 and the 100 mg and 200 mg tablets on 2004-07-23.